• Project status: Active

Research area: Clinical Sciences > Emergency 

sick child in hospital

PRagMatic paediatric trial of balanced vs normal saline fluid in sepsis (PRoMPT BOLUS).

PRoMPT BOLUS is a large clinical trial that will enrol over 8,000 children with sepsis across the United States, Canada, Australia, and New Zealand.

PRoMPT BOLUS is a large clinical trial that will enrol over 8,000 children with sepsis across the United States, Canada, Australia, and New Zealand.

Overview

The goal of PRoMPT BOLUS is to compare 0.9 per cent saline and balanced fluids that are both commonly used in routine clinical care. Both fluids are helpful to treat paediatric sepsis, but we do not know which fluid is the safest and most effective.

PRoMPT BOLUS is a large pragmatic clinical trial, meaning the study conditions mimic ‘real life’ as much as possible. The study has a simple inclusion criteria, few exclusion criteria, and very few elements of care that are protocolised. PRoMPT BOLUS will enrol over 8,000 children with sepsis across the United States, Canada, Australia, and New Zealand.

Find out more about PRoMPT BOLUS:

Purpose

Approximately 2,500 children outside the newborn period die from septic shock each year in the U.S. and thousands more die worldwide. Despite widespread implementation of resuscitation protocols, contemporary studies still report 2 to 6 per cent mortality for children with septic shock treated in the paediatric ED.

Crystalloids are the standard resuscitative fluid for septic shock. 0.9 per cent saline and balanced fluids (Plasma-Lyte 148, Ringer’s Lactate, and Hartmann’s Solution) are inexpensive, stable at room temperature, and nearly universally available with identical storage volumes and dosing strategies. Notably, both are also of proven clinical benefit in septic shock.

However, 0.9 per cent saline is used in 80 to 95 per cent of cases of paediatric septic shock, despite data supporting that balanced fluid resuscitation may have superior efficacy and safety. The high chloride content of 0.9 per cent saline has been associated with acute kidney injury, acidemia, hyperkalaemia, vascular permeability, inflammation, coagulopathy, fluid overload, and death.

Balanced fluids have shown a 1 to 4 per cent absolute mortality reduction and up to 50 per cent lower odds of dialysis compared to 0.9 per cent saline in observational and non-randomised interventional studies in adult sepsis. Because definitive conclusions could not be drawn from existing observational and non-randomised studies, 0.9 per cent saline overwhelmingly remains the most commonly used fluid based on historical precedent (particularly in paediatrics).

To definitively test the comparative effectiveness of 0.9 per cent saline versus balanced fluids, a well-powered randomised controlled trial (RCT) is necessary.

Frequently asked questions

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